US20070162064A1 - Lancet casing - Google Patents

Abstract

An improved protective lancet, lancet casing and method for producing the same. The lancet casing includes a lancet body that is integrally molded about an elongated shaft portion of a lancet needle. The lancet body is characterized in having an upper bearing surface from which a pointed end of the lancet needle extends. The lancet casing further includes a cap integrally molded about the pointed end of the lancet needle and joined to the lancet body by a narrow frangible junction on the upper bearing surface of the lancet body. In accordance with the present invention, one or more tab members are affixed between the cap and the body. Each of the one or more tab members includes a persistently affixed upper end integrally molded to the outer contour of the cap and a detachably affixed lower end integrally molded to or near a peripheral edge of the upper bearing surface of the lancet body to provide a readily perceptible user indication of the status of whether or not the cap member has been re-attached or tampered with.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a divisional of U.S. patent application Ser. No. 10/364,782, filed on Feb. 11, 2003, which claims the benefit of and priority from U.S. provisional patent application Ser. No. 60/364,478 filed on Mar. 15, 2002 and U.S. design patent application Ser. No. 29/171,683 filed on Nov. 26, 2002 and the contents of each is incorporated herein by this reference.
BACKGROUND OF THE INVENTION
• 1. Technical Field
• The present invention relates in general to the field of medical lancet devices that utilize protective caps for user safety and security. More particularly, the invention relates to such devices capable of covering the lancet needle to protect from unintended puncturing during storage and handling and to maintain sterility prior to use. Additionally, the invention relates to providing a method of assuring that lancets are limited to one-time use only. Specifically, the invention provides a method for indicating whether the lancet's protective cap has been removed and re-attached to prevent re-use and to detect tampering.
• 2. Description of the Related Art
• Lancets and their uses are well known in the art as a convenient and safe means for piercing or pricking a person's skin to draw small amounts blood that can then be subjected to a variety of medical tests such as for blood sugar content. A typical integrated lancet design is as described in U.S. Pat. No. 3,358,689, with a lancet needle encased in an elongated plastic body. The lancet needle tip is embedded in a protective cap that is integrally molded with a plastic body to form a single integral unit prior to use.
• Lancets are designed to draw a relatively minute quantity of blood from capillaries immediately below the surface of the skin and are commonly used by the patients themselves at home as well as by medical professionals in medical offices and hospitals. Lancets are used to prick the patient's skin either by manual penetration or in conjunction with a dynamic (usually spring-driven) mechanical device into which the lancet unit is installed and then removed after use. In the home setting, most lancets are used by the patient with the mechanical device, which is designed to accept lancets of various sizes. In the medical office and hospital setting, lancets are often used manually in order avoid the necessity of having to re-sterilize the mechanical device after each use.
• Lancets are specifically designed to safely accommodate their purpose as “pricking” devices that are common utilized by non-medically trained individuals including children. Specifically, in order to effectuate a safe and controlled puncturing of a patient's skin, the exposed tip of the needle extends only a very short distance (typically a few millimeters) from the flat upper surface of the lancet body, which acts as a bearing to limit the puncture depth. The needle may extend from the upper surface using any well known lancet configurations, such as by having the needle protrude outward from the lancet body or by otherwise affixing the needle to the upper surface. Together, these signature structural and dimensional characteristics of lancet design give rise to another nearly universal lancet design feature, namely, a single unitary molded plastic casing that includes a plastic cap that covers the lancet tip. The cap is integrally molded with the lancet “body” which encases most of the needle shaft and provides the bearing surface as explained above. The cap is moldedly bonded to the top surface of the lancet body at a relatively narrow neck or seal boundary, such that a user can remove the cap with relative ease using a twisting motion just prior to use. In addition to its compatibility with the short needle/bearing structural design of lancets, the unitary plastic encasement promotes additional safety by providing reliable sterilization from the heat of injection molding and subsequent airtight encasement. These basic tenets of lancet design have consistently provided a safe and effective blood sampling means that has remained fundamentally unchanged for many years.
• A problem arises, however, concerning safety after a lancet has been used to draw blood. After the lancet unit has been used to prick the patient's skin, either manually or by means of a mechanical lancing device, the sharp lancet tip is contaminated with the patient's blood. As with any instrument or device that has been exposed to blood, a used lancet unit constitutes a significant biological hazard that must be handled with care. Therefore, after use and prior to ultimate disposal of the lancet unit, the cover cap may be re-attached to prevent accidental contact by circumstantially vulnerable persons such as sanitation workers or janitors with the extremely sharp tip of the lancet.
• However, the solid casing structure in which the cap and body form a single continuous outer casing presents difficulties relating to a user's ability to identify a re-attached lancet cap and therefore to distinguish a used from an unused lancet unit. A re-attached lancet cap is not easily recognizable because the cap is replaced in flush surface-to-surface abutment against the lancet body at a very small frangible junction necessitated by the need for relative ease of the original detachment. Consequently the re-attached cap/body appear as a continuous unit tending to obscure visual evidence of any prior disengagement and closely resembling the original unbreached unit. The foregoing general design characteristics of lancets also hinder a user's ability to identify a used lancet unit by “feel.” A re-attached cap is either snugly reinserted into the original molded cavity from which the needle was originally withdrawn, or, due to the difficultly encountered in attempting to insert the needle into the cap's miniscule extant cavity, the cap is forcibly impaled on the needle at a different surface location. The tight fit of the impaled cap combined with the friction offered by the semi-adhered plastic-on-plastic surface boundary between the cap and the lancet body result in subsequent cap “detachments” requiring a significant amount of force which may easily be mistaken as that required for the initial cap detachment. Thus, there is not always a materially noticeable difference between the look or feel of removing a lancet cap for the first time and the look or feel of subsequent detachments.
• Since lancets are commonly stored in bags or boxes of more than fifty, the inability to readily and reliably distinguish between used and unused lancets creates significant health and safety problems in which contaminated lancets may be used and then replaced into the storage bag among unused lancets for re-use without the knowledge of the next user. Given the many prevalent blood-borne diseases such as hepatitis, a single such misidentification is potentially catastrophic. Additionally, federal regulations and requirements of the health care industry, such as Medicare, contain provisions that medical and heath providers cannot use or stock returned lancet inventory without definite certainty that the returned items have not been used or tampered with.
• It can therefore be appreciated that a need exists for an improved lancet design that overcomes the foregoing problems associated with visual and tactile misidentification of used lancets. The present invention addresses such needs.
SUMMARY OF THE INVENTION
• An improved protective lancet, lancet casing and method for producing the same are disclosed herein. The lancet casing includes a lancet body that is integrally molded about an elongated shaft portion of a lancet needle. The lancet body is characterized in having an upper bearing surface from which a pointed end of the lancet needle extends. The lancet casing further includes a cap integrally molded about the pointed end of the lancet needle and joined to the lancet body by a narrow frangible junction on the upper bearing surface of the lancet body. In accordance with the present invention, one or more tab members are affixed between the cap and the body. Each of the one or more tab members includes a persistently affixed upper end integrally molded to the outer contour of the cap and a detachably affixed lower end integrally molded to or near a peripheral edge of the upper bearing surface of the lancet body to provide a readily perceptible user indication of the status of whether or not the cap member has been re-attached or tampered with.
• The above as well as additional objects, features, and advantages of the present invention will become apparent in the following detailed written description.
BRIEF DESCRIPTION OF THE DRAWINGS
• The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself however, as well as a preferred mode of use, further objects and advantages thereof, will best be understood by reference to the following detailed description of an illustrative embodiment when read in conjunction with the accompanying drawings, wherein:
• FIG. 1 illustrates an improved lancet unit and lancet casing as manufactured prior to usage in accordance with one embodiment of the present invention;
• FIG. 2 depicts the improved lancet unit shown inFIG. 1 with the lancet cap detached;
• FIG. 3 illustrates the lancet unit depicted inFIG. 2 with the lancet cap re-attached;
• FIG. 4 depicts an improved lancet unit and lancet casing as manufactured prior to usage in accordance with an alternate embodiment of the present invention;
• FIG. 5 illustrates an improved lancet unit in accordance with an alternate embodiment of the present invention; and
• FIGS. 6A-6B depicts alternate lancet tab dispositions for preventing tampering and reducing the required detachment force in accordance with alternate embodiments of the present invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
• This invention is described in a preferred embodiment in the following description with reference to the figures. While this invention is described in terms of the best mode for achieving this invention's objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the present invention.
• The present invention is directed to a new type of protective lancet casing unit that provides readily perceptible evidence of prior lancet usage or tampering by providing an indication of whether or not the cap has been previously removed or partially detached. As explained in further detail with reference to the figures, an improved lancet and lancet casing are disclosed which provide such evidence of prior use or tampering by implementation of a boundary attachment, or tab member that attaches at one end to a lancet cap and at the other end to the lancet body. In accordance with the embodiments disclosed herein, the relative thickness of the molding used at the points of contact between the tab and the protective cap and the surface of the lancet is controlled such that by applying a thicker amount of molding at one of these points of contact and a thinner molding at the other, the attachment will consistently break-off from the thinner attachment. Thus, the user can routinely identify whether a detachment has occurred by visually inspecting the same location on each lancet.
• With reference to the figures, wherein like reference numerals refer to like and corresponding parts throughout, and in particular with reference toFIG. 1, there is illustrated an improved lancet unit having a lancet casing as manufactured prior to usage in accordance with one embodiment of the present invention. Specifically, alancet unit10 is depicted as generally including an outer encasement molded directly about a lancet needle which is comprised of a generally cylindrical elongated shaft portion6 and having a pointed end section15 depicted inFIG. 2. Consistent with conventional skin pricking applications for which it is designed,lancet unit10 is a relatively small device having a length typically ranging from three to five centimeters.
• Lancet unit10 includes alancet body2 that is generally cylindrical in form with generally cylindrical end sections connected by a small diameter axial cylindrical section. The top portion oflancet unit10 comprises a cap member4 that is integrally and sealably joined tolancet body2 by afrangible junction3 that is preferably of a reduced diameter so thatfrangible junction3 can be readily fractured to detach cap member4 from anupper bearing surface5 by exerting a twisting or pulling force, as by rotating cap member4 relative tolancet body2. In the depicted embodiment, cap member4 has a rounded edge contour extending well beyond the outer diameter oflancet body2. Furthermore, cap member4 includes opposing face surfaces to provide a relatively flat or disc-like member that can be conveniently grasped between the ends of the thumb and forefinger when it is desired to rotatably detach cap member4 relative tolancet body2.
• In a preferred embodiment, a plastic mold injection process is utilized to integrally join cap member4 withlancet body2 wherein cap member4 is molded about the pointed end section15 andlancet body2 is molded about lancet needle shaft6. In this manner, when cap member4 is detached fromlancet body2, the pointed end section15 is exposed, extending from the substantially flatupper bearing surface5 of the lancet body. The pointed end section15 may extend from theupper bearing surface5 using any well-known lancet configurations, such as by having the needle protrude outward from thelancet body2 or by otherwise affixing the needle to theupper bearing surface5. It will be apparent from the foregoing description of the embodiment depicted in the figures that the lancet encasement comprised oflancet body2 and cap member4 serves both as an integral support to holdlancet unit10 prior to and during use and as a container to protectively and sealably enclose pointed end section15 untillancet unit10 is ready for use. In addition to providing a grippable body by whichlancet unit10 can be maneuverably handled, the flatupper bearing surface5 oflancet body2 serves as a bearing for limiting the depth of penetration of the lancet needle to a few millimeters into human skin.
• The pointed end section15 of the lancet needle is completely enclosed and sealed by cap member4, which is formed integrally withlancet body2 and sealably joined therewith so that the pointed end is protected from external sources of contamination prior to use. During use, cap member4 is detached fromlancet body2 to expose the pointed end section15 of the lancet needle which is then used to pierce a patient's skin either manually by hand pressing the lancet or as deployed in a mechanically driven lancet device. The lancet and protective cap may be manufactured using one or more of a variety of suitable materials such as semi-rigid plastics, which are suitable for manufacturing using well-known injection molding manufacturing techniques. Likewise the needle may be of any type of material known in the art, such as stainless steel.
• In accordance with the present invention,lancet unit10 further includes an additional attachment means usefully deployed as an integrally adapted member of the outer encasement comprising cap member4 andlancet body2. Specifically, and as illustrated inFIG. 1, a pair oftab members8 are disposed between cap member4 and the upper/outer edge oflancet body2. In the depicted embodiment, each oftab members8 are plastic strips which taper inward from awider tab base12 integrally joined with the side edge of cap member4 to a narrower tear-awayend14 affixed toupper bearing surface5. The relative width oftab base12 ensures that responsive to a twisting removal action,tab member8 will remain attached at its upper end to cap member4 while the lower tear-away joint14 will disengage fromupper bearing surface5 oflancet body2 substantially simultaneously with fracturing offrangible junction3.
• In an alternative embodiment, each oftab members8 are plastic strips which taper outward from a narrower tear-away end affixed to the side edge of cap member4 to a wider tab base integrally joined with theupper bearing surface5. The relative width of the tab base ensures that responsive to a twisting removal action,tab member8 will remain attached at its lower end to theupper bearing surface5 oflancet body2 while the upper tear-away joint will disengage from cap member4 substantially simultaneously with fracturing of the frangible junction.
• As further depicted inFIG. 1, each oftab members8 is attachably disposed such that a substantial gap is formed between the edge of cap member4 and the extended strip portion of each oftab members8 betweentab base12 and tear-awayend14. Furthermore,tab members8 are affixed in mutual diametric opposition withtab members8 disposed on the outer contour edge of cap member4 to facilitate ease of disengagement of cap member4 by providing a balanced rotational lever effect. In the depicted embodiment, wherein cap member4 has side edges extending beyond the axial diameter oflancet body2 andtab members8 attached thereto at tab bases12 and extending inwardly toward the attachment points onupper bearing surface5, a twisting force on cap member4 is multiplied as applied on the narrower diameter of the points of attachment of tear-away ends14 onupper bearing surface5 thereby facilitating ease of disengagement oftab members8.
• FIG. 2 depicts theimproved lancet unit10 shown inFIG. 1 with the lancet cap member4 disengaged fromlancet body2. As shown inFIG. 2, when cap member4 is detached fromlancet body2, an exposed pointed end section15 extends a short distance fromupper face5, which provides a depth control bearing surface. The pointed end section15 oflancet unit10 can be formed in any suitable manner but preferably is provides with one or more sharp cutting edges which will effectuate bleeding from the capillaries immediately below the surface of the skin for drawing a small drop of blood from a patient's finger or other suitable piercing site.
• Detachment of cap member4 fromlancet body2 is effectuated by fracturing its base contact atfrangible junction3 immediately surrounding the base perimeter of pointed end section15 while substantially simultaneously breaking the molded joint between the tear-awayend14 and theupper bearing surface5. Such detachment is typically effectuated by a hand twisting motion in which the suitably disk shaped cap member4 is grasped between a user's thumb and index finger while thelancet body2 is grasped by the fingers of the user's other hand. In the depicted embodiment, this detachment technique is effective for the flat-faced, disk like cap member4 by providing a well-suited lever for applying sufficient force to simultaneously detach the pair oftab members8 fromupper bearing surface5 of the lancet body. In a preferred embodiment, and as shown inFIG. 2,tab members8 disengage fromlancet body2 at or near the lower tear-away ends14 such that a minimum amount of plastic molding residue remains which will not appreciably affect the shape or contour oflancet body2 thus preventing any potential interference by such residue withupper bearing surface5 or with the fitting of the uncapped lancet into a lancing device. The minimal amount of plastic mold material remaining on upperlancet body face5 after detachment of cap member4 may usefully provide a post re-attachment visual indicator that cap member4 has previously been detached fromlancet body2.
• With reference toFIG. 3, there is illustrated the lancet unit depicted inFIG. 2 with the cap member4 re-attached tolancet body2. As shown inFIG. 3, the edge contour of cap member4 includes taperedside edges9 from which a substantial gap19 extends therebetween totab members8. Gaps19 facilitate unobstructed viewing of theupper bearing surface5 both when cap member4 is originally attached or re-attached tolancet unit10. Specifically, the gaps19 between each of taperedside edges9 and the medial strip portions oftab members8 affords an unobstructed and open view at virtually any perspective viewing angle of the points onupper bearing surface5 at which tear-away ends14 are or were moldedly affixed to reveal the present condition of the tear-away ends14 as either attached to or disengaged fromupper bearing surface5. It should be noted that although taperededge9 is depicted in the disclosed embodiments as a straight line taper, alternative taper angles such as a concave taper wherein taperededge9 slopes at an inward curvature toward the central axis of cap member4 may be employed consistent with the spirit and scope of the present invention.
• As depicted inFIG. 3, visually perceptible evidence of the original disengagement of cap member4 such as a stretched, jagged, and/or twisted appearance of tear-away ends14, and the structural disengagement of tear-away ends14 from their original attachment points23 onupper bearing surface5 are all readily perceptible with the open view forum provided by gaps19. In this manner, the mutual orientation oftab members8 with respect to cap member4 andlancet body2 provides a user with a greatly enhanced opportunity to visually inspect whether or nottab members8 have been detached from thelancet body2. In the alternative, the gaps19 provide a user a tactile indicator wherein the user may push either oftab members8 inward toward thetapered edge9 of cap member4 to ascertain whether or not tear-awayend14 remains fixed tolancet body2.
• The embodiment set forthFIGS. 1-3 further illustratestab members8 as havingtab base12 affixed at the edge of cap member4 at the point where the taperededge9 of cap member4 begins withtab members8 extending tangentially downward from this point to theupper bearing surface5 oflancet body2. This arrangement increases the user's ability to inspect the tab both visually and by touch to determine whether it has been previously detached. In addition,tab members8 may be formed of a color in contrast with the color oflancet body2 to further aid in visually identification of the discontinuity betweentab members8 andlancet body2. While the preferred embodiment includes the use of two diametrically opposed tab members, alternate implementations of the present invention may be implemented in which a single tab member or more than two are similarly deployed.
• Referring toFIG. 4, there is depicted an improved lancet unit and lancet casing as manufactured prior to usage in accordance with an alternate embodiment of the present invention. Specifically, alancet unit20 is illustrated, which like the embodiment depicted inFIGS. 1-3 includes cap member4 integrally molded to alancet body2. In contrast to the embodiment depicted inFIGS. 1-3,lancet unit20 includes a pair of integrally moldedtab members28 each having a medial tear-away joint17 disposed between the points at which each oftab members28 attaches to cap member4 andlancet body2. As shown inFIG. 4, medial tear-away joint17 comprises a substantially narrowed neck junction that will more readily fracture upon application of a twisting or pulling force applied between cap member4 andlancet body2. In this manner, when cap member4 is detached fromlancet body2, a substantial appendage portion of theoriginal tab member8 remains attached to cap member4 while a visually perceptible stub remains theupper bearing surface5 oflancet body2. Medial tear-away joint17 is preferably disposed within one to three millimeters from the attachment toupper bearing surface5 such that the remaining stub provides a readily perceptible indicator of de-attachment while not unduly interfering with the surface contour ofupper bearing surface5.
• With reference toFIG. 5, there is illustrated animproved lancet unit30 in accordance with an alternate embodiment of the present invention. Specifically,lancet unit30 includes a pair oftab members25 that are persistently affixed at respective tab bases16 above afulcrum boundary18 on the curved edge contour of cap member4. As utilized herein, “fulcrum boundary” refers to the outermost point at or near the diametric center axis of a disc-shaped or partially disc-shaped cap member4 such as the partially disc-shaped cap members depicted inFIGS. 1-5. As shown in the depicted embodiment, each oftab members25 is integrally attached to cap member4 only at the molded junctions comprising tab bases16 from which the tab members extend downward and inward toward their respective attachment point onupper bearing surface5. The downward and inward extension oftab members25 fromtab bases16 results in an upper portion of each oftab members25 resting or pressing in non-adhered surface contact against the curved outer edge contour of cap member4 along a pair of diametrically opposednon-adhered boundaries21. Withtab members25 moldedly attached at its ends between cap member4 andlancet body2, thenon-adhered boundaries21 formed betweentab members25 and the convex curved outer contour of cap member4 extends fromtab base16 to the point belowfulcrum boundary18 at which each oftab members25 departs tangentially from the edge surface of cap member4 whereintab members25 extend downwardly and inwardly to their respective attachment points onupper bearing surface5 oflancet unit30.
• In accordance with the depicted embodiment, tear-away ends14 are detachably affixed by plastic molding or another suitable attachment technique such thattab members25 are pressed against the surface of cap member4 alongnon-adhered boundary21. Upon detachment of cap member4 fromlancet body2 wherein tear-away ends14 are disengaged fromupper bearing surface5, the released tear-away ends14 oftab members25 are urged outward as and upward by the tension maintained at tab bases16 as applied at thefulcrum boundary18. In this manner, upon re-attachment of cap member4 tolancet body2,tab members25 are slightly splayed further enabling a user to readily make a reliable visual determination that cap member4 has been previously detached.
• FIGS. 6A and 6B depict alternate lancet tab dispositions for preventing tampering and reducing the required detachment force in accordance with alternate embodiments of the present invention. Specifically,FIG. 6A illustrates animproved lancet unit35 having a pair oftab members26, which similar totab members8 oflancet unit10, are persistently affixed at an upper end to the side edge of disc-like cap member4 and detachably affixed a lower end toupper bearing surface5. As shown inFIG. 6A,tab members26 are pre-set in a “pre-twisted” disposition in which each oftab members26 extends angularly from its attachment point on cap member4 to the corresponding attachment points onupper bearing surface5. In the depicted embodiment, the angled extension oftab members26 reduces the required rotation distance required to impart a tab fracturing force thus facilitating ease of disengagement of thetab members26 from upper bearing surface upon twisting cap member4 in a counterclockwise direction with respect toupper bearing surface5.
• Referring toFIG. 6B, alancet unit45 is illustrated in which each of a pair of tab members32 are pre-set in mutually opposing “pre-twisted” dispositions with tab member32aangled to facilitate ease of detachment in the clockwise direction and with tab member32bangled to facilitate ease of detachment in the counterclockwise direction. In this manner, one or the other of tab members will be disengaged fromupper bearing surface5 upon even the slightest twist of cap member4 in either direction thus providing enhanced tamper resistance forlancet unit45.
• While this invention has been described in terms of several embodiments, it is contemplated that alterations, permutations, and equivalents thereof will become apparent to one of ordinary skill in the art upon reading this specification in view of the drawings supplied herewith. It is therefore intended that the invention and any claims related thereto include all such alterations, permutations, and equivalents that are encompassed by the spirit and scope of this invention.

Claims (15)

1. A protective lancet casing comprising:

a lancet body having an upper surface from which a pointed end of a lancet needle extends;

a cap member abutting the upper surface of said lancet body for encasing the pointed end of the lancet needle;

at least one tab member affixed at an upper end to said cap member and affixed at a lower end to said lancet body;

wherein said at least one tab member is permanently affixed at the upper end to said cap member and permanently affixed at the lower end to said lancet body, and wherein said at least one tab member includes a detachable junction between the upper and lower ends.

2. The protective lancet casing ofclaim 1, wherein said at least one tab member is tapered such that the upper end forms a wider molded junction with said cap member and the lower end forms a wider molded junction with said lancet body and wherein said at least one tab member includes a narrower molded detachable junction between the upper and lower ends.

3. The protective lancet casing ofclaim 1, wherein the upper surface of the lancet body is substantially flat for providing a bearing surface with respect to the pointed end of the lancet needle.

4. The protective lancet casing ofclaim 1, wherein said lancet body, said cap member, and said at least one tab member are integrally molded as a single unit by a mold injection process.

5. The protective lancet casing ofclaim 1, wherein said cap member has an outer contour that tapers inward toward the upper surface of said lancet body such that a substantial gap is formed between the tapered contour and the lower end of the at least one tab member.

6. A protective lancet casing comprising:

a lancet body having an upper surface from which a pointed end of a lancet needle extends;

a cap member abutting the upper surface of said lancet body for encasing the pointed end of the lancet needle;

at least one tab member affixed at an upper end to said cap member and affixed at a lower end to said lancet body;

wherein said at least one tab member includes two tab members attached in diametric opposition on said lancet body.

7. The protective lancet casing ofclaim 6, wherein each of the two diametrically opposing tab members are pre-disposed at opposite twist angles to facilitate detachment of the lower end of one of the two tab members in a clockwise twist direction and detachment of the lower end of the other of the two tab members in a counterclockwise twist direction.

8. The protective lancet casing ofclaim 6, wherein each of the two diametrically opposing tab members are pre-disposed at a twist angle to facilitate ease of detachment of the respective lower ends of both of the two tab members upon twisting in one twist direction.

9. The protective lancet ofclaim 8, wherein the twist angle of both of the two diametrically opposed tab members facilitates twisting detachment in either the clockwise or counterclockwise direction with respect to the upper surface of said lancet body.

10. A lancet unit comprising:

an integrally molded plastic encasement housing a lancet needle, wherein said encasement includes:

a body member molded about a shaft portion of the lancet needle, said body member including an upper bearing surface from which a pointed end section of the lancet needle protrudes;

a cap member molded about the pointed end section of the lancet needle; and

at least one plastic strip member extending between said cap member and said body member, said at least one plastic strip member affixed at an upper end to said cap member and affixed at a lower end at or near the periphery of said upper bearing surface such that a visually perceptible gap is formed between said lower end of said at least one plastic strip member and said cap member;

wherein the upper end of the at least one plastic strip member is integrally affixed above a fulcrum boundary point on a curved outer contour of said cap member such that an upper portion of the at least one plastic strip member is in non-adhered surface contact with a portion of the curved outer contour of said cap member.

11. The lancet unit ofclaim 10, wherein the at least one plastic strip member departs tangentially from the non-adhered surface contact with the curved outer contour of said cap member.

12. The lancet unit ofclaim 10, wherein said at least one plastic strip member comprises two plastic strip members.

13. The lancet unit ofclaim 12, wherein each of the two plastic strip members are pre-disposed at opposite twist angles to facilitate detachment of the lower end of one of the two plastic strip members in a clockwise twist direction and detachment of the lower end of the other of the two plastic strip members in a counterclockwise twist direction.

14. The lancet unit ofclaim 12, wherein each of the two plastic strip members are pre-disposed at a twist angle to facilitate ease of detachment of the respective lower ends of both of the two plastic strip members upon twisting in one twist direction.

15. The lancet unit ofclaim 14, wherein the twist angle of both of the two plastic strip members facilitates twisting detachment in either the clockwise or counterclockwise direction with respect to the upper surface of said body member.

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